BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER POLI-GRIP

    MDR report key: 1812364 · Received August 18, 2010

    Report

    Report Number
    MW5017168
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    May 1, 2009
    Report Date
    July 29, 2010
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED SUPER POLI-GRIP, FIXODENT CONTROL, AND SEA-BOND FROM APPROXIMATELY (B)(6) 2001 UNTIL STILL USING. WHILE I WAS USING THESE PRODUCTS, I BEGAN EXPERIENCING NUMBNESS AND TINGLING IN MY EXTREMITIES. IN (B)(6) 2009 I WAS DIAGNOSED WITH NEUROPATHY. DOSE OR AMOUNT: DENTURE CREAM. FREQUENCY: TWICE DAILY. ROUTE: ORAL. DATES OF USE: (B)(6) 2001 -- PRESENT. DIAGNOSIS OR REASON FOR USE: DENTURE ADHESIVE CREAM. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLI-GRIP NONE KOL UNK
    2 FIXODENT CONTROL NONE KOO PROCTOR & GAMBLE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| S